NCT02278874

High Risk Multiple Gestation Study

Development of Non-invasive Prenatal Diagnostic Test for Multiple Gestation Pregnancies Based on Fetal DNA Isolated From Maternal Blood

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 99 (actual)
• Sponsor: Natera, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objectives of the clinical study are to demonstrate the accuracy of our proprietary algorithm method to determine the genetic health of the developing fetuses in a multiple gestation pregnancy from a maternal blood sample. The long term goal of this study will be the development of a method of minimally invasive prenatal diagnosis that has a higher sensitivity and lower false positive rate in the intended population (e.g. multiple gestation pregnancies) than other currently available screening tests. This will result in fewer unnecessary amniocenteses and Chorionic Villus Sample (CVS) procedures, which are associated with a risk of miscarriage.

Conditions

• Trisomy 13
• Trisomy 18
• Trisomy 21
• Sex Chromosome Abnormalities

Timeline

• Start date: 2014-08-01
• Primary completion: 2018-12-01
• Completion: 2019-03-01
• First posted: 2014-10-30
• Last updated: 2019-06-13

Locations

4 sites across 1 country: United States